KUBTEC Medical Imaging
Research And Development Manager
111 Research Dr, Stratford, CT 06615
Associate Research Scientist
January 1995 to May 1999
October 2013 to November 2014
60 Trigo Drive, Middletown, Connecticut 06457
October 2012 to September 2013
Carestream Health Molecular Imaging
Applications Lab Director
October 2009 to September 2012
Fujifilm Medical Systems USA, Inc.
Site, Laboratory Director | Environmental Health, Safety
February 2006 to September 2009
EASTMAN KODAK MOLECULAR IMAGING SYSTEMS
Senior Scientist | Environmental Health, Safety
June 1999 to April 2006
New Haven, CT
Adjunct Research Scientist
January 1998 to January 2002
January 1990 to January 1998
Edwards Lifesciences/CAS Medical
Quality Assurance Manager - ForeSight Products
August 2016 to February 2020
Hampford Research Inc
Quality System Specialist
August 2015 to August 2016
Provider of bimodal medical imaging systems for for OR and pathology labs as well as dependable x-ray and bimodal imaging for Industry and Research markets. Provider of bimodal medical imaging systems for for OR and pathology labs as well as dependable x-ray and bimodal imaging for Industry and Research markets.
What company does John Pizzonia work for?
John Pizzonia works for KUBTEC Medical Imaging
What is John Pizzonia's role at KUBTEC Medical Imaging?
John Pizzonia is Research And Development Manager
What industry does John Pizzonia work in?
John Pizzonia works in the Medical Devices industry.
Research And Development Manager @ KUBTEC Medical Imaging Provider of bimodal medical imaging systems for for OR and pathology labs as well as dependable x-ray and bimodal imaging for Industry and Research markets. 111 Research Dr, Stratford, CT 06615Associate Research Scientist @ Yale University Developing a Grant Funded research program. From January 1995 to May 1999 (4 years 5 months) Director Quality @ NatureMost Laboratories NatureMost is a provider of Nutraceutical (vitamin, mineral and herbal) dietary supplements with annual sales of 2 million dollars. They have been in business for over 40 years.Maintain operations of a cGMP manufacturing facility and testing laboratory. Manage ten employees and operating budget of $150,000. Implemented FDA Part 111/cGMP Quality programs and ensured OSHA and BSL2 laboratory safety compliance.Achievements:• Increased revenue by 20% within a year after assuming company operations and quality control after owner’s departure. Quickly learned product capsule and tablet formulation for existing products maintaining quality and developing three new products. • Addressed FDA 483 warning letter received prior to employment. Developed remediation program working with FDA to bring facility operations and products into cGMP compliance.• Set up Vendor Audit Program for cGMP Supplier Qualification Requirement. Established on-site audits with 15 vendor inspections of facilities and documentation. • Reduced testing costs by designing and building a BL2- ISO17025 microbial testing laboratory submitted for accreditation. From October 2013 to November 2014 (1 year 2 months) 60 Trigo Drive, Middletown, Connecticut 06457Laboratory Director @ Bruker Biospin BRUKER BIOSPIN CORPORATION is a provider of preclinical PET, SPECT, MRI, CT and optical imaging solutions based state of the art continuous crystal, ultra-high field USR magnets and back thinned CCD camera designs. These systems are the industry leaders for small animal in vivo imaging and are marketed worldwide to academic and industrial markets with annual developed sales of $50 million. Laboratory DirectorManager of a 4,000 sq. ft. laboratory with an operating budget of $300,000 consisting of wet bench facilities, a vivarium, and product demo showroom. Orchestrate all aspects of Site EHS including general, chemical (CSO and EPA interface), nuclear Radiation Safety Officer (NRC interface), and a small animal vivarium (IACUC compliant program). Managed the product development (ISO9000 and IS14000) and regulatory compliance interface for a globally marketed respiratory support system ensuring domestic and local regulatory compliance.Achievements:• Integrated Quality, Safety and Regulatory Programs to new owner’s corporate structure. Worked with company coordinators to align documentation and processes with Bruker’s best business practices. Prepared worldwide regulatory compliance for X-ray and anesthesia/rebreathing systems. Established smooth R&D and Sales operations to maintain new product development and existing revenue streams. • Designed new laboratory facility to support PET/SPECT product R&D and customer training. Worked with architects, operations and management to design facility including a wet laboratory, vivarium and product demonstration showroom. Facility constructed on schedule meeting all company objectives. • Secured Radioactive Materials License to support laboratory product development. From October 2012 to September 2013 (1 year) Woodbridge, CTApplications Lab Director @ Carestream Health Molecular Imaging CARESTREAM MOLECULAR IMAGING SYSTEMS is a provider of preclinical optical, PET, SPECT, and CT imaging solutions based on CCD camera and state of the art continuous crystal designs. Systems for both in vitro as well as small animal in vivo imaging needs were marketed worldwide to academic and industrial markets with annual developed sales of $32 million. Applications Lab DirectorManaged 4,000 sq. ft. laboratory with a staff of five and a $250,000 operating budget. Maintained operations for wet bench laboratory facility, a small animal vivarium and product demonstration showroom. Instituted Lean Six Sigma applications, site safety requirements and GLP policy procedures.Achievements:• Established Federal Health Service compliance for OSHA, EPA, DEA, NRC and DEEP. Developed program meeting all local, state and federal safety requirements for fire, electrical, chemical, radiation, biological, first aide, industrial hygiene and ergonomics. Maintained Schedule II Controlled Substances License with the DEA. • Developed product and facility regulatory compliance as Radiation Safety Officer. Maintained PET isotope research and X-ray program with the NRC and FDA for worldwide product distribution.• Established an Institutional Animal Care and Use Committee and served as the local IACUC Coordinator. Designed and implemented a rodent vivarium to support R&D, Sales and Customer Support. Completed application for Office of Laboratory Animal Welfare accreditation.• Addressed product defects by implementation of Lean Six Sigma Principles to track and decrease out-of-box defects by 65% and improving customer satisfaction by 20%.• Developed in-house preclinical imaging demonstrations resulting in four direct system sales. From October 2009 to September 2012 (3 years) Woodbridge, CTSite, Laboratory Director | Environmental Health, Safety @ Fujifilm Medical Systems USA, Inc. FUJIFILM MEDICAL SYSTEMS USA is a provider of CCD camera systems, laser-based scanners and surface Plasmon resonance (SPR); label free screening solutions for US Academic and Industrial markets with annual developed sales of $7 million. Laboratory/Site DirectorSelected to setup and manage the life science wet laboratory and demonstration showroom in Woodbridge, Connecticut. Served as Applications and Facilities director for 4,700 sq. ft. wet laboratory and product demonstrations area managing an annual operating budget of $200,000. Managed laboratory staff and developed an ISO9000/ISO14000 Quality System based on the Fuji’s corporate model. Developed OSHA compliant General Safety Program. Compiled documentation and provided training for Electrical issues, Emergency Action/Exit Plans, Fire Prevention, Personal Protective Equipment, Equipment Safety, Lock-out Tag-out procedures, Hazard Communication, Bloodborne Pathogens, Ergonomics and Industrial Hygiene. Maintained safety program with internal facility audit program. Achievements:• Selected to establish Fujifilm Medical Systems in the US Market. Managed wet laboratory providing R&D and Sales support. Started facility developing Quality System documentation and training. Prepared ISO9001/13485/14000 registrations for business unit and facility.• Developed OSHA compliant General Safety Program maintaining an accident free facility for three years. • Provided technical sales support at customer sites throughout the US and Canada managing up to nine sales representatives. Team effort increased annual sales by $100,000.• Increased Fujifilm Life Sciences revenue by reducing operational expenses by 14% for three years while maintaining product quality and facility safety. Returned Business Unit to profitability resulting in a product portfolio sale to GE Healthcare. From February 2006 to September 2009 (3 years 8 months) Woodbridge, CTSenior Scientist | Environmental Health, Safety @ EASTMAN KODAK MOLECULAR IMAGING SYSTEMS Senior ScientistServed as an Application Scientist providing customer technical support. Promoted to Laboratory Manager and served as Safety Manager. Ensured laboratory compliance with corporate guidelines and local, state and federal laws. Led System 9000 software integration and ISO 9001-quality program to achieve compliance and certification. Achievements:• Selected as Laboratory Manager leading R&D and Sales support of a five state art digital imaging system release. • Developed sales demonstrations for customer site presentations. • Served as Business Unit Safety Manager ensuring biological, chemical, nuclear and environmental safety while maintaining laboratory efficiency. • Prepared standard operating procedures and documentation for securing ISO9001 certification. Completed registration, training, and BRU audits required for US and European distribution. • Developed Corrective Action program to address declining customer satisfaction during the transition from film to digital imaging solutions. Resolved 97% of CA request improving customer satisfaction and new product acceptance.• Expanded Digital Imaging Systems to include small animal vivarium preclinical imaging applications. Provided new product to offset losses from declining film sales. From June 1999 to April 2006 (6 years 11 months) New Haven, CTAdjunct Research Scientist @ Yale University Actively participated in a Neurosurgery program project grant focused on cryptogenic epilepsy.· Established and maintained tissue culture facility creating primary cell systems from human abortive fetal tissue and surgically resected human brain tissue for research.· Performed independent experiments looking to correlate oxidative stress with seizure activity. From January 1998 to January 2002 (4 years 1 month) Postdoctoral Fellow @ Yale University ranking among the top medicalschools and receives funding from the National Institutes of Health. From January 1990 to January 1998 (8 years 1 month) Quality Assurance Manager - ForeSight Products @ Edwards Lifesciences/CAS Medical From August 2016 to February 2020 (3 years 7 months) Branford, CTQuality System Specialist @ Hampford Research Inc I am presently working on a ISO9001 implementation project for Hampford Research Inc. HRI is a specialty manufacturer of precision organic chemicals that is undergoing rapid growth primarily due to exceptional quality inherent in their culture. Using their ProcessPro ERP tools and newly acquired UniPoint Quality Management software I am completing work on an ISO9001/14001 integration and revision against the 2015 standard. From August 2015 to August 2016 (1 year 1 month) Stratford, CT
Extraversion (E), Intuition (N), Feeling (F), Judging (J)
3 year(s), 8 month(s)
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